Best Chinese Medicines LLC – FDA Warning Letter, Sep 1, 2026

The U.S. Food and Drug Administration (FDA) issued a warning letter dated October 23, 2026, to Best Chinese Medicines LLC regarding the marketing of unapproved new drugs. This action followed a regulatory review of the company’s website conducted in September 2026. The FDA identified several products, including Dissolve Mass Stasis Breaker, Gynostemma Leaf, Wenxin Keli, Lianhua Qingwen Capsules, and Duhuo Jisheng Wan, as being in violation of federal standards. The primary issue cited was that these products were marketed with claims to diagnose, treat, or prevent serious medical conditions such as tumors, hypertension, heart disease, COVID-19, and arthritis. Under the regulatory framework of the Federal Food, Drug, and Cosmetic Act, any product intended for such therapeutic uses is classified as a drug and must undergo an FDA approval process to confirm it is safe and effective before being sold. Since these products lacked the necessary approvals, their distribution in interstate commerce is prohibited. The FDA has required Best Chinese Medicines LLC to submit a written response within fifteen business days detailing the specific steps taken to correct these violations. The company must also provide a plan to prevent future recurrences and provide documentation of their corrective actions. Failure to address these concerns promptly may result in legal actions, including product seizures or injunctions.